# K042644: Aeskulisa TTG a and Aeskulisa TTG G

- Pathway: 510(k) (Traditional)
- Applicant: Aesku, Inc.
- Decided: Jun 1, 2005 after 247 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102490: Igx Plex Celiac Qualitative Assay (2011), 1 descendant of its own
- K140691: IG_Plex Celiac DGP Panel (2014), 0 descendants of its own
- K102964: EU-TTG Iga  and EU-TTG Igg (2011), 0 descendants of its own

## Recalls of this device
- Apr 3, 2019 · Class II · Z-1800-2020: An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is larg

## Indications for use
AESKULISA tTg A is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig A antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings. AESKULISA tTg G is a solid phase enzyme immunoassay for the semi-quantitative and qualitative detection of Ig G antibodies against tissue transglutaminase (tTG) in human serum. The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

Source page: https://510kreport.com/device/K042644
Methodology: https://510kreport.com/methodology